Application Nr Approved Date Route Status External Links
ANDA076159 2013-09-20 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Glipizide Extended-Release Tablets Is Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus. Glipizide Extended-Release Tablets Are A Sulfonylurea Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus. Limitations Of Use: Not For Treatment Of Type 1 Diabetes Or Diabetic Ketoacidosis. 1.1 Limitations Of Use Glipizide Extended-Release Tablets Are Not Recommended For The Treatment Of Type 1 Diabetes Mellitus Or Diabetic Ketoacidosis.

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Butylated Hydroxytoluene BUTYLATED HYDROXYTOLUENE Molecular
2. Cellulose Acetate CELLULOSE ACETATE Unresolved
3. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
4. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
5. Hypromelloses HYPROMELLOSES Unresolved
6. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
9. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
10. Sodium Chloride SODIUM CHLORIDE Unresolved GRAS-Generally recognized as safe.
11. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Glipizide GLIPIZIDE ZINC537795

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